GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

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9.1.7.5 Other Alkenes Repeated Patch Insult Test Human Neodene 18 Alpha Olefin (1-octadecene) Non sensitising 9.2 Repeat Dose Toxicity 9.2.1 2-week, dermal Rat/Fischer 344 Gulftene 12-16 NOAEL = 1 000 mg/kg 9.2.2 Other Alkenes 4-week, dermal Rabbit/NZ White C16 - C18 Slight hyperemia, 9.2.3 Up to 51 days, oral Rat/ Sprague Dawley Crl:CD BR VAF/Plus 1-tetradecene (blend from three suppliers) 9.2.4 13-week, oral Rat/ Crl:CD BR C20 - C24 Alkenes, Branched and Linear exfoliation, oedema NOAEL = 1 000 mg/kg/day for reproductive neurotoxic effects; NOAEL = 100 mg/kg/day for systemic effects in females. No NOAEL for males NOAEL = 500 mg/kg/day 9.3 Genetic Toxicity 9.3.1 in vitro 9.3.1.1 Bacterial reverse S.typhimurium, E.coli C20 - C24 Alkenes, branched and linear Negative with & w’out mutation assay activation 9.3.1.2 Unscheduled DNA Rat hepatocyte primary Gulftene 12 – 16 Negative Synthesis culture 9.3.1.3 BALB/3T3 Mouse embryo cells Gulftene 12 – 16 Negative Transformation Test BALB/3T3-A31-1-1 9.3.1.4 HGPRT Assay Chinese Hamster Ovary Gulftene 12 – 16 Negative with & w’out cell activation FULL PUBLIC REPORT 26 April 2000 NA/713 Page 22 of 100
9.3.1.5 Chromosome aberration Human peripheral C20-C24 Alkenes, branched and linear Negative with & w’out lymphocytes activation 9.3.1.6 Other Alkenes Bacterial Reverse S.typhimurium, E.coli 1-Octadecene Negative with & w’out Mutation Assay activation Mitotic Recombination Rat liver RL1 cells. 1-Octadecene Negative with & w’out activation Chromosome Aberration H18 Rat liver RL1 cells. 1-Octadecene Negative with & w’out activation 9.3.2 in vivo 9.3.2.1 Micronucleus Assay, intraperitoneal injection 9.3.2.2 Micronucleus Assay, dermal administration Mouse/ Crl:CD-1 (ICR) BR Mouse/Crl:CD-1 (ICR) BR Gulftene 12 – 16 Negative C20 - C24 Alkenes, branched and linear Negative FULL PUBLIC REPORT 26 April 2000 NA/713 Page 23 of 100
Page 1 and 2: File No: NA/713 26 April 2000 NATIO
Page 3 and 4: 3. PHYSICAL AND CHEMICAL PROPERTIES
Page 5 and 6: Hydrolysis as a Function of pH: Dis
Page 7 and 8: No definitive test results for the
Page 9 and 10: 18 and are automatically discharged
Page 11 and 12: esultant oil/water emulsion is pass
Page 13 and 14: The results for a modified Sturm te
Page 15 and 16: was also performed according to the
Page 17 and 18: 9. EVALUATION OF TOXICOLOGICAL DATA
Page 19 and 20: 9.1.2 Dermal Toxicity 9.1.2.1 Rabbi
Page 21: 9.1.6.1 Rabbit/NZ White C12 - C16 A
Page 25 and 26: Clinical observations: A few days a
Page 27 and 28: LD50: > 5 000 mg/kg Result: C20-24
Page 29 and 30: 9.1.1.7 Acute Oral Toxicity of Othe
Page 31 and 32: hair at the treatment site. Morphol
Page 33 and 34: Result: C20-24 Alkenes, branched an
Page 35 and 36: 9.1.3 Inhalation Toxicity 9.1.3.1 A
Page 37 and 38: FULL PUBLIC REPORT 26 April 2000 NA
Page 39 and 40: Draize score abraded skins: Time af
Page 41 and 42: 9.1.5.3 Acute Dermal Irritation of
Page 43 and 44: Mean group score (24, 48 & 72 hour
Page 47 and 48: Draize scores: Time after Animal #
Page 51 and 52: Draize scores of non irrigated eyes
Page 53 and 54: 9.1.6.3 Acute Eye Irritation of C16
Page 55 and 56: Draize scores of irrigated eyes: Ti
Page 57 and 58: 9.1.7 Skin Sensitisation 9.1.7.1 Sk
Page 59 and 60: that sensitisation may have been in
Page 61 and 62: Number of animals: 20 test animals,
Page 63 and 64: liver parenchyma. Result: Repeated
Page 65 and 66: Pathology: F0 males and satellite f
Page 67 and 68: were observed at the end of the rec
Page 69 and 70: negative control. The positive cont
Page 71 and 72: increases in the incidence of aberr
Page 73 and 74:
Clinical observations: No mortality
Page 75 and 76:
hour observation and crust formatio
Page 77 and 78:
10. ASSESSMENT OF ENVIRONMENTAL EFF
Page 79 and 80:
with 42% less growth (relative to t
Page 81 and 82:
10.2 TESTS ON MARINE ORGANISMS Exot
Page 83 and 84:
6.25% WAF 5 of the test animals had
Page 85 and 86:
NOEL (96 h) < 0.09 g/L FULL PUBLIC
Page 87 and 88:
the 48 hour NOEL was less than 1 90
Page 89 and 90:
11. ASSESSMENT OF ENVIRONMENTAL HAZ
Page 91 and 92:
R65 - May Cause Lung Damage if Swal
Page 93 and 94:
14. MATERIAL SAFETY DATA SHEET The
Page 95 and 96:
Gerarde, H. (1963) Toxicological St
Page 97 and 98:
Safepharm Laboratories Limited (199
Page 99 and 100:
Wildlife International Ltd (1995) 1
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GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

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